LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection (cUTI)

Inclusion Criteria:

- Male and female patients 18 to 85 years of age with suspected and/or bacteriologically
documented complicated UTI judges by the investigator to be serious (required patient
to be hospitalized for treatment with intravenous antibiotics)

Exclusion Criteria:

- Urine Gram stain that demonstrated that a Gram-positive organism was present, or if
urine culture results were available, demonstrated Gram- positive organisms were
present at ≥10E5 CFU/mL

- Urine culture result available at enrollment and demonstrating more than 2 different
species of microorganisms regardless of the colony count

- Urine culture result available demonstrating fungal UTI with colony count >10E3 CFU/mL

- Patient had received prior antibiotics within 72 hours before the initiation of study
therapy

- Patients with estimated glomerular filtration rate < 30mL/min calculated based in
study qualified formula